一项评估卡度尼利单抗在晚期实体瘤患者中的 1a/1b 期首次人体研究（COMPASSION-01）。
A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors.
机构信息
Department of Medical Oncology, Monash Health, Melbourne, Australia; Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
Medical Oncology Department, Austin Health, Melbourne, Australia.
出版信息
Cell Rep Med. 2023 Nov 21;4(11):101242. doi: 10.1016/j.xcrm.2023.101242. Epub 2023 Oct 17.
Simultaneous inhibition of programmed cell death protein-1 (PD-1) and cytotoxic T lymphocyte-associated protein-4 (CTLA-4) with bispecific antibodies may improve efficacy over single-agent treatment while limiting toxicity. Cadonilimab is a humanized, bispecific antibody targeting PD-1 and CTLA-4. This is a phase 1 study of cadonilimab including dose escalation (n = 39) and dose expansion (n = 80). One dose-limiting toxicity event is observed, with the maximum tolerated dose not reached. 6 mg/kg cadonilimab once every 2 weeks is established as the recommended dose for future studies. The most common treatment-related adverse event is infusion-related reaction (18.5%), mostly grade 1/2 in severity. The incidences of any grade and grade ≥3 immune-related adverse events are 44.5% and 6.7%, respectively. The confirmed overall response rate is 13.4%, and the median duration of response is 12.9 months. Cadonilimab is well tolerated and showed promising efficacy in patients with advanced solid tumors. This study is registered with ClinicalTrials.gov: NCT03261011.
同时抑制程序性死亡蛋白-1（PD-1）和细胞毒性 T 淋巴细胞相关蛋白-4（CTLA-4）的双特异性抗体可能会提高疗效，同时限制毒性。Cadonilimab 是一种针对 PD-1 和 CTLA-4 的人源化双特异性抗体。这是一项 Cadonilimab 的 1 期研究，包括剂量递增（n=39）和剂量扩展（n=80）。观察到 1 例剂量限制毒性事件，未达到最大耐受剂量。6 mg/kg Cadonilimab 每 2 周一次被确定为未来研究的推荐剂量。最常见的治疗相关不良事件是输注相关反应（18.5%），严重程度大多为 1/2 级。任何等级和≥3 级免疫相关不良事件的发生率分别为 44.5%和 6.7%。确认的总缓解率为 13.4%，缓解持续时间中位数为 12.9 个月。Cadonilimab 具有良好的耐受性，并在晚期实体瘤患者中显示出有希望的疗效。该研究在 ClinicalTrials.gov 上注册：NCT03261011。
Zotero 插件